Real-World Evidence真实世界证据
Real-world evidence is clinical evidence derived from the analysis of real-world data collected during routine healthcare delivery, including electronic health records, insurance claims, disease registries, and patient-reported outcomes. In regulatory submissions, post-market surveillance reports, and market-access dossiers, it complements randomized controlled trial data by describing how a product performs in broader patient populations and everyday clinical practice outside controlled research settings.
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Check source meaning → confirm the preferred term → record approved variants and references.
Where this term appears
In translation and localization, real-world evidence content appears in post-market surveillance summaries, observational study protocols, market-access dossiers, payer communication materials, and regulatory responses. Translators must preserve distinctions between real-world data and real-world evidence, keep endpoint definitions stable, and adapt epidemiological terms while maintaining the registry or database names used in each market.
Translation checks
A frequent mistake is translating real-world evidence as if it were equivalent to randomized controlled trial evidence, or using the same term for real-world data and real-world evidence. This can mislead reviewers about the strength of conclusions. Another error is rendering registry names or endpoint definitions inconsistently across documents, which makes cross-file comparisons unreliable.
Keep the term aligned across your files
Check intended use, warnings, document versions and approved terminology with the project team. Translation supports documentation; it does not establish product approval or regulatory acceptance.
Provide approved terms and previous translations with the source files. Agree how variants, ambiguous wording and revisions will be reviewed. Terminology maintenance and any termbase handback are confirmed in the project scope. See the 8-step AI + expert workflow.
Related document experience
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Read the published project →Published scope shows related industry experience; it does not confirm that this specific term was used or reviewed in the project.
Working on life science documentation?
Include the source and target languages, file types, intended use, deadline and any approved termbase. Agree handling before sending sensitive files. Acknowledged in 4 hours, quoted in 24.
Prepare an inquiry email →Life Science solutions →File handling →A glossary entry is not an official standard or evidence of regulatory acceptance. Confirm current requirements for your project separately.